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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021612
Company: CIPHER PHARMS INC

Products on NDA 021612

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIPOFEN	FENOFIBRATE	50MG	CAPSULE;ORAL	Prescription	None	Yes	No
LIPOFEN	FENOFIBRATE	100MG	CAPSULE;ORAL	Discontinued	None	Yes	No
LIPOFEN	FENOFIBRATE	150MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021612

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/11/2006	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021612lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/21612s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021612_lipofen_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/06/2025	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021612s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021612s026ltr.pdf
06/03/2021	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021612s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021612Orig1s024ltr.pdf
05/15/2019	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021612s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021612Orig1s020ltr.pdf
05/18/2018	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021612s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021612Orig1s018ltr.pdf
11/06/2018	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021612s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021612Orig1s017ltr.pdf
12/23/2015	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
01/18/2013	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021612s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021612Orig1s014,s015ltr.pdf
01/18/2013	SUPPL-14	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021612s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021612Orig1s014,s015ltr.pdf
01/18/2013	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
10/31/2011	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021612s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021612s007ltr.pdf
12/12/2008	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021612s002, s004ltr.pdf
12/12/2008	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021612s002, s004ltr.pdf

Labels for NDA 021612

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/06/2025	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021612s026lbl.pdf
06/03/2021	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021612s024lbl.pdf
05/15/2019	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021612s020lbl.pdf
11/06/2018	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021612s017lbl.pdf
05/18/2018	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021612s018lbl.pdf
01/18/2013	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021612s014s015lbl.pdf
01/18/2013	SUPPL-14	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021612s014s015lbl.pdf
10/31/2011	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021612s007lbl.pdf
01/11/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021612lbl.pdf

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